BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM

    MDR report key: 1213688 · Received October 23, 2008

    Report

    Report Number
    2028159-2008-00384
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 23, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K021566
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM WITH NO PROBLEMS FOUND. THE PHACO HANDPIECES WERE ALSO EXAMINED WITH NO PROBLEMS FOUND. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. CORNEAL BURN IS AN ISSUE THAT IS OCCASIONALLY REPORTED WITH CATARACT SURGERY. ACCORDING TO THE ECRI HEALTH DEVICES, HAZARD UPDATE: SCLERAL AND CORNEAL BURNS DURING PHACOEMULSIFICATION, NOVEMBER 1996, VOL. 25, NO. 11:426-431 MOST CORNEAL BURNS CAN BE TRACED TO ISSUES RELATED TO SURGICAL TECHNIQUE AND NO TO MALFUNCTIONING EQUIPMENT. A LETTER AND COPY OF THIS INDUSTRY ARTICLE WAS PROVIDED TO THE CUSTOMER. THIS REPORT WAS MAILED TO FDA ON: 10/23/2008.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT A PATIENT SUFFERED A CORNEAL IMPRINT, THOUGHT TO BE CAUSED BY HEAT DURING PHACO. THE WOUND WAS NOT SUTURED. THE SURGEON COULD NOT TELL WHAT CAUSED THIS PROBLEM. THE SURGEON CONFIRMED THAT THE HEADPIECES ARE BEING CLEANED AT THE HOSPITAL WITH AN AUTOMATIC WASHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI